Manager of Regulatory Affairs Remote & Hybrid Only Jobs in New Jersey
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare...
RemoteSenior Director, Regulatory Affairs - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 2 days ago
- Bridgewater, NJ
- 2 days ago
At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare...
RemoteAssociate Director, Regulatory Affairs Project Planning & Coordination
- ACADIA Pharmaceuticals Inc.
- Princeton, NJ
- 12 days ago
- Princeton, NJ
- 12 days ago
About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around...
HybridDirector, Regulatory Affairs - Development Strategy
- Insmed Incorporated
- Bridgewater, NJ
- 15 days ago
- Bridgewater, NJ
- 15 days ago
At Insmed, every moment and every patient counts and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare...
RemoteAssociate Director, Regulatory Affairs Advertising & Promotion - Digital & Corporate Communications
- AbbVie
- Florham Park, NJ
- 45+ days ago
- Florham Park, NJ
- 45+ days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
HybridSenior Director, Regulatory Affairs
- ADC Therapeutics America Inc
- New Providence, NJ
- 45+ days ago
- New Providence, NJ
- 45+ days ago
Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented...
HybridDirector, Regulatory Affairs Operations
- ADC Therapeutics America Inc
- New Providence, NJ
- 45+ days ago
- New Providence, NJ
- 45+ days ago
Transforming Cancer Therapy Together At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented...
Hybrid- Tris Pharma
- Monmouth Junction, NJ
- 45+ days ago
- Monmouth Junction, NJ
- 45+ days ago
Apply Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD,...
HybridAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Florham Park, NJ
- 60+ days ago
- Florham Park, NJ
- 60+ days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
HybridAssociate Director, Regulatory Affairs (Advertising and Promotion)
- Bausch Health Companies Inc.
- Bridgewater, NJ
- 90+ days ago
- Bridgewater, NJ
- 90+ days ago
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference....
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in New Jersey offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- ICH Guidelines
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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